Performing Hazard Analysis & Defining Control Measures (QMS)

QualityOne Vaults provide the HACCP Flow Diagram for managing a HACCP plan, enabling a broad view of the manufacturing process for a product.

You can use the Information panel on the HACCP Flow Diagram to perform hazard analysis for elements in a HACCP Plan, giving you a clear picture of where hazards are introduced in your plan and how they are controlled.

Hazard Analysis Process Overview

Performing hazard analysis using the HACCP Flow Diagram involves the following steps:

• Add a Process Hazard Analysis to a HACCP Plan Process Step or HACCP Plan Process Step Group
• Add Hazards
• Perform risk assessment on significant Hazards
• Determine how Hazards will be controlled and define control measures based on the outcome of the hazard analysis
• Assess hazard analysis completeness

Adding a Process Hazard Analysis

You can perform hazard analysis for each Process Step and Process Step Group in your HACCP plan that could introduce a hazard.

To begin hazard analysis, create or select one (1) or more Process Hazard Analysis records to add to a Process Step or Process Step Group on the HACCP Flow Diagram. A Process Hazard Analysis can be associated with one (1) or many Process Steps or Process Step Groups, but not both.

To begin hazard analysis for a Process Step or Process Step Group, do the following:

1. Navigate to the appropriate HACCP tab or to Business Admin > Objects > HACCP Plans.
2. Select a HACCP Plan and launch the HACCP Flow Diagram.
3. Click the Edit Mode button.
4. Select a Process Step or Process Step Group on the HACCP Flow Diagram’s canvas.
5. Open the Information panel by clicking the Additional Information () icon at the top of the HACCP Flow Diagram.
6. Do one (1) of the following:
   • To add or remove existing Process Hazard Analyses to or from a Process Step:
     1. In the Information panel, click the binoculars () icon in the Process Hazard Analyses section header.
     2. In the dialog, you can do the following:
        • Select one (1) or more existing Process Hazard Analysis. Process Hazard Analyses related to different Process Steps in the same HACCP Plan and Process Hazard Analyses with no associated HACCP Plan are available to select.
        • Deselect any existing associated Process Hazard Analyses that are not relevant to the selected HACCP Plan Process Step.
        • Click Create to create a new Process Hazard Analysis to add to the selection list.
     3. Click Save.
   • To create a new Process Hazard Analysis to add to a Process Step or Process Step Group:
     1. In the Information panel, click the plus (+) icon in the Process Hazard Analyses section header.
     2. Enter a Name.
     3. Recommended: Select the Hazard Classification.
     4. Recommended: Select the Hazard Classification Group.
     5. Recommended: Select the Origin & Nature of the hazards.
     6. Recommended: Select the Risk Category.
     7. Click Save or Save + Create.

When you create a new Process Hazard Analysis from the HACCP Flow Diagram, Vault automatically associates it with the HACCP Plan you are editing. You cannot reassign an already-assigned Process Hazard Analysis to a different HACCP Plan.

After adding the Process Hazard Analysis, expand the section for the Process Hazard Analysis record in the Information panel to see additional sections.

Potential Hazard Description

The Potential Hazard Description section displays under an expanded Process Hazard Analysis record in the Process Hazard Analyses section if the Potential Hazards Identified field on the Process Hazard Analysis record is “Yes”. This section displays the Hazard Classification, Hazard Classification Group, Origin & Nature of the hazards, and Risk Category, as well as additional fields, depending on your Admin’s configuration and the type of Process Step.

Depending on the Process Hazard Analysis field values and the type of Process Step, some values in this section may be editable. Click the Edit () icon in the Potential Hazard Description section header to update or add values, and click Save when you’re done editing. Updating values in this section may affect which Process Hazard Analysis sections and fields display. For example, deleting the Hazard Classification field value removes the associated Hazards, clears the Hazard Risk Assessment, and resets the Decision Tree to a default state.

Adding Hazards

If the Potential Hazards Identified field value on the Process Hazard Analysis is “Yes”, the Hazards section displays in the Information panel. You can add and remove Hazards on a Process Hazard Analysis by selecting from a list of Hazards that share the same Hazard Classification value. To add Hazards to analyze, do the following:

1. Click the binoculars () icon in the section header.
2. Select one (1) or more Hazards to associate.
3. Click Save.

Assessing the Risks of Hazards

After adding Hazards to your Process Hazard Analysis, you can perform risk assessment for the hazards using the Risk Matrix you specified in the Risk Category field. The Hazard Assessment section displays when the Potential Hazard Identified value is “Yes”.

To perform risk assessment for the hazards in your Process Hazard Analysis, do the following:

1. Click the Edit () icon in the Hazard Assessment section header.
2. Enter information about the Hazard’s Severity, Likelihood, and Local Likelihood.
3. Click Save.

When you save updates to this section, Vault calculates values for the following fields:

• Significant Hazard
• CCP
• OPRP
• PRP
• Subsequent Step
• Control Measure
• Modification

The calculated field values determine the sections that display after the Hazard Assessment section.

Categorizing Control Measures

The Categorization of Control Measures section helps you to assess if the hazards described in your Process Hazard Analysis are properly controlled and determine the required types of control measures. The section uses a series of questions to assess if hazards should be controlled with a subsequent step, critical control such as a CCP (critical control point) or OPRP (operational prerequisite program), or other control measure such as a PRP (prerequisite program).

To complete this section, do the following:

1. Click the Edit () icon in the section header.
2. Select an answer for Will subsequent step eliminate/reduce? and enter a justification.
3. Select an answer for Are control measures verified? and enter a justification.
4. Select an answer for Feasible to establish critical limits? and enter a justification.
5. Click Save.

Depending on the answers you provide, Vault may not display all questions.

The answers you provide in the Categorization of Control Measures section determine the subsequent sections that appear after you click Save. The possible outcomes are the following:

• Control Measures
• PRP
• Subsequent Steps
• CCP
• OPRP
• Modification

Details about the possible outcomes are in the following sections.

Control Measures

The Control Measures section lets you select one (1) or more Control Measure type CCP Library records to create new Control Measure type PRP/CM - Hazard Analysis records.

To add a Control Measure to your Process Hazard Analysis:

1. Click the binoculars () icon in the section header.
2. Select or deselect one (1) or more Control Measure type CCP Library records in the dialog.
3. Click Save.

This section displays up to 15 Control Measures with a link to view more.

PRP

The PRP section lets you select one (1) or more PRP type CCP Library records to create new PRP type PRP/CM - Hazard Analysis records.

To add a PRP to your Process Hazard Analysis:

1. Click the binoculars () icon in the section header.
2. Select or deselect one (1) or more PRP type CCP Library records in the dialog.
3. Click Save.

This section displays up to 15 PRPs with a link to view more.

Subsequent Steps

The Subsequent Steps section lets you specify one (1) or more Process Steps that control the Hazards in the Process Hazard Analysis. When you add Subsequent Steps to this section, Vault creates a new PHA - Subsequent Step record. Removing Subsequent Steps deletes previously created PHA - Subsequent Step records.

To add or remove a Subsequent Step:

1. Click the binoculars () icon in the section header.
2. In the dialog, do the following:
   • Select one (1) or more HACCP Plan Process Steps.
   • Deselect previously added Subsequent Steps.
3. Click Save.

This section displays up to 15 Subsequent Steps with a link to view more.

CCP

The CCP section lets you create one (1) or more CCP-Hazard Analysis records of Critical Control Point type (CCP) to add to your Process Hazard Analysis. Creating a CCP in this section adds a CCP to the selected Process Step or Process Step Group.

To create a CCP:

1. Click the plus (+) icon in the section header.
2. Enter a Name.
3. Optional: Select a CCP to reference a CCP type CCP Library record.
4. Enter any additional details.
5. Click Save.

When you add a CCP to a Process Step or Process Step Group, Vault displays a CCP label on the left of Process Steps and on the right of Process Step Groups on the HACCP Flow Diagram. Process Steps and Process Step Groups each display up to five (5) CCP and OPRP labels combined. If a Process Step or Process Step Group has more than five (5) CCP and OPRP labels combined, four (4) labels display along with an Actions menu to view more.

To remove a CCP from a Process Step or Process Step Group, click Delete record () next to a CCP in the CCP section.

OPRP

The OPRP section lets you create one (1) or more CCP-Hazard Analysis records of OPRP type (OPRP) to add to your Process Hazard Analysis. Creating an OPRP in this section adds an OPRP to a Process Step or Process Step Group.

To create an OPRP:

1. Click the plus (+) icon in the section header.
2. Enter a Name.
3. Optional: Select an OPRP to reference an OPRP type CCP Library record.
4. Enter any additional details.
5. Click Save.

When you add an OPRP to a Process Step or Process Step Group, Vault displays an OPRP label on the left of Process Steps and on the right of Process Step Groups on the HACCP Flow Diagram. Process Steps and Process Step Groups each display up to five (5) CCP and OPRP labels combined. If a Process Step or Process Step Group has more than five (5) CCP and OPRP labels combined, four (4) labels display along with an Actions menu to view more.

To remove an OPRP from a Process Step or Process Step Group, click Delete record () next to an OPRP in the OPRP section.

Modification

The Modification section displays when modification of HACCP Plan is required, either through a Control Measure or Subsequent Step, to control the Hazards introduced by the selected Process Step or Process Step Group.

To create a Modification:

1. Click the plus (+) icon in the section header.
2. Enter a Name.
3. Enter any additional details.
4. Click Save.

Assessing Hazard Analysis Completeness

When you’ve finished hazard analysis for a HACCP Plan Process Step or HACCP Plan Process Step Group and added your control measures, update the Hazard Analysis Complete field on the HACCP Plan Process Step or HACCP Plan Process Step Group record.

You can assess hazard analysis completeness for a HACCP Plan by clicking the Hazard Analysis Completeness Check () icon at the top of the HACCP Flow Diagram. When you run this action, Vault checks the Hazard Analysis Complete field value on HACCP Plan Process Step and HACCP Plan Process Step Group records and displays the status on each Process Step and Process Step Group on the HACCP Flow Diagram. Clicking the icon again hides the icons on Process Steps and Process Step Groups.